Medical Device Test & Validation Engineer

IPG Photonics Corporation; Marlborough (MA); On-site; USD 75,000 - 87,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Tuition reimbursement

Employee Stock Purchase Plan (ESPP)

Paid time off

Job summary

IPG Photonics Corporation in Marlborough, MA is seeking a Verification and Validation Test Engineer to design, build, and validate test methods for medical devices in an ISO 13485 and FDA QSR compliant environment.

You will support R&D through Production, author protocols and data sheets, and apply statistical methods to assess performance. This role requires 1–3 years in a medical device or regulated industry and working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering.
• 1–3 years of engineering experience within the medical device or regulated industry.
• Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.
• Direct experience in planning and/or execution of Verification and Validation for complex electrotechnical devices.
• Proficiency with data acquisition systems, and proficiency in analysis tools such as Excel and Python, or statistical software like Minitab.
• Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors.

Responsibilities

• Execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables.
• Design, develop, validate and execute test methods to inform design decisions and verify system functionality.
• Author test protocols, data sheets, and final reports; author/assist manufacturing procedures and machine instructions.
• Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
• Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets.
• Present test findings to stakeholders and communicate risk and countermeasure insights.

Skills

Data acquisition

Statistical analysis

Python

Excel

Minitab

Lab equipment

Education

Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering

Tools

Data acquisition systems

Python

Excel

Minitab

Linux

Job description

IPG Photonics Corporation in Marlborough, MA is seeking a Verification and Validation Test Engineer to design, build, and validate test methods for medical devices in an ISO 13485 and FDA QSR compliant environment.

You will support R&D through Production, author protocols and data sheets, and apply statistical methods to assess performance. This role requires 1–3 years in a medical device or regulated industry and working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.